Ornidazole - IP/IH (Anti protozole or Anti ameobics)

Tests Specification
Description White to yellowish white crystalline powder
Solubility Soluble in chloroform and in methanol
Identification It responds to the following test A and B
A, IR: The infrared absorption spectrum of the test substance exhibits maximum at the same wave-length as that of a similar preparation of Ornidazole WRS.
B, B, UV : In the range of 230 nm to 360 nm, a 0.002 % w/v solution of test sample in 0.1M hydrochloric acid shows absorption maximum at about 277 nm and Absorbance at 277 nm should be between 0.580 to 0.630
Heavy metals Not more than 20 ppm
Water Not more than 1.0%
Sulphated Ash Not more than 0.1%
Related compounds by HPLC
  1. Individual known impurity:
    1. 2-methyl-5-nitro imidazole : Not more than 0.2%
  2. Total impurities : Not more than 1.0%
Assay on anhydrous basis (by potentiometer) Not less than 98.0 per cent and not more than 101.0 per cent w/w of C7H10CIN3O3 calculated on anhydrous basis.